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| Name | Class |
|---|---|
| Shire | INDUSTRY |
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The primary objective of the study is to assess the benefice of Vyvanse on the factors that cause impairments in driving behavior in individuals with ADHD using a driving simulation aimed at examining the factors that cause impairments in driving behavior in individuals with ADHD such as driving speed, collision risk, and visual attention of 60 young drivers (ages 18-24) with ADHD. We hypothesize: 1.) young adults with ADHD treated with Vyvanse will show lower velocity (speed) scores and spend less time driving over the posted speed limit in the driving simulation when compared to subjects taking a placebo; 2.) young adults with ADHD treated with Vyvanse will show a lesser likelihood to collide with a suddenly appearing peripheral object, less difficulty maintaining the vehicle within their lane, and a lesser likelihood of driving through stop signs and solid red traffic lights without slowing down when compared to subjects taking a placebo; and 3.) young adults with ADHD treated with Vyvanse will exhibit more focused visual attention on details in the visual field when compared to subjects taking a placebo while driving. In addition, young adults with ADHD treated with Vyvanse will exhibit less visual tunneling and shorter off-road glances when compared to subjects taking a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vyvanse | Active Comparator | Patients may be randomized to the active comparator arm. Participants randomized to this arm will receive 30, 50, or 70mg Vyvanse daily. |
|
| Placebo | Placebo Comparator | Patients may be randomized to the placebo comparator arm. Those randomized to this arm will receive 30, 50, or 70mg placebo daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vyvanse | Drug | Vyvanse 30, 50, or 70 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants Experiencing Collisions During "Surprise Events" in Driving Simulator | Initial results from a one hour driving simulation in the MIT AgeLab Driving Simulator as compared to second session in the simulator following a 6-week trial on Lisdexamfetamine or placebo. During the simulation, "surprise events," designed to test the participant's attention and driving, occurred. This outcome presents the difference in number of collisions experience by individuals treated with Vyvanse or Placebo. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with a clinically significant abnormality according to cardiology consultation (ECGs with clinically concerning intervals including PR, QTC, QRS, will be reviewed by cardiology).
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Biederman, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Cambridge | Massachusetts | 02138 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23174471 | Derived | Biederman J, Fried R, Hammerness P, Surman C, Mehler B, Petty CR, Faraone SV, Miller C, Bourgeois M, Meller B, Godfrey KM, Baer L, Reimer B. The effects of lisdexamfetamine dimesylate on driving behaviors in young adults with ADHD assessed with the Manchester driving behavior questionnaire. J Adolesc Health. 2012 Dec;51(6):601-7. doi: 10.1016/j.jadohealth.2012.03.005. Epub 2012 Apr 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vyvanse | |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Signed Consent |
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| |||||||||||||||||||||
| Received Study Drug/Placebo |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vyvanse | |
| BG001 | Placebo | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants Experiencing Collisions During "Surprise Events" in Driving Simulator | Initial results from a one hour driving simulation in the MIT AgeLab Driving Simulator as compared to second session in the simulator following a 6-week trial on Lisdexamfetamine or placebo. During the simulation, "surprise events," designed to test the participant's attention and driving, occurred. This outcome presents the difference in number of collisions experience by individuals treated with Vyvanse or Placebo. | Participants who completed the protocol, including endpoint Driving Simulation assessment, were analyzed (61 in total). | Posted | Number | participants | 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vyvanse |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Biderman, MD | Massachusetts General Hospital | 617-726-1746 |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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| Placebo | Drug | Placebo 30, 50, 70 mg daily |
|
| NOT COMPLETED |
|
|
Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 35 |
| 30 |
| 35 |
| EG001 | Placebo | 0 | 34 | 20 | 34 |
| Mucosal Dryness | General disorders | Systematic Assessment |
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| Tense/Jittery | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Headaches | General disorders | Systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
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| Cold/Infection/Allergy | Infections and infestations | Systematic Assessment |
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| Agitated/Irritable | Psychiatric disorders | Systematic Assessment |
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| Sad/Down | Psychiatric disorders | Systematic Assessment |
|
| Autonomic | General disorders | Systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Genitourinary | Renal and urinary disorders | Systematic Assessment |
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| Increased Energy | General disorders | Systematic Assessment |
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| Cardiovascular | Cardiac disorders | Systematic Assessment |
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| Decreased Energy | General disorders | Systematic Assessment |
|
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| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |